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OpenTrials
Completed

NCT Number: NCT03681834

Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery

The Cor-Knot® device is an automated knotting system for valve sutures and prosthetic rings used for more than a year during valve replacements and annuloplasties in cardiac surgery. It reduces the time spent knotting the threads fixing the prosthesis and thus reduces aortic clamping and extracorporeal circulation times. The originality of the project is based on the absence of national multi-rate data collection on the effectiveness and safety of the Cor-Knot® knotting device.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • programmed minimally invasive surgery for:
  • aortic valve replacement
  • mitral valve replacement
  • mitral valve plastic surgery
  • adult patient

Exclusion criteria

  • emergency surgery

Treatment and study plan

Data Collection

Other

Data on the effectiveness and safety of the Cor-Knot® knotting device

Primary outcomes

  1. Presence of periprosthetic leak around the prosthetic rings as determined during physical examination (rated yes/no )

    Time frame: Day 30

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: RECORVA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 24, 2018
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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